Cybrexa Therapeutics Announces First Patient Dosed with First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Trial in Ovarian Cancer: https://www.cybrexa.com/news/#
About CBX-12
CBX-12 is a first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex™ technology to enhance delivery of exatecan to tumor cells and is composed of a pH-Low Insertion Peptide (pHLIP®), a linker, and exatecan. CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase 1 inhibition by delivering exatecan, a highly potent, second-generation topoisomerase 1 inhibitor, directly to the tumor cells. As an antigen-independent therapy, CBX-12 may have broad utility in patients who are not eligible for antigen-targeted therapies, including monoclonal antibodies and antibody-drug conjugates (ADCs), and has potential for use in combination regimens with other anti-cancer agents and immunotherapies.
About the alphalex™ Technology Platform
The Cybrexa alphalex technology is a novel antigen-independent, peptide-drug conjugate platform that enables targeted delivery of highly potent anti-cancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptide (pHLIP®), a linker, and a small molecule anti-cancer agent. pHLIP peptides are a family of pH-low insertion peptides that target acidic cell surfaces. pHLIP was developed at Yale University and the University of Rhode Island and is exclusively licensed to pHLIP, Inc., and Cybrexa is a sublicensee of pHLIP, Inc.
About Cybrexa Therapeutics
Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent, tumor-targeting peptide-drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa is on a mission to create therapeutics that revolutionize the standard of care in oncology, and its robust pipeline aims to combat breast, ovarian, non-small cell lung cancer, and a range of other tumors. Its assets are built on Cybrexa’s alphalex™ technology platform, which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven, Connecticut and was founded in 2017. For more information, please visit www.cybrexa.com or follow us on LinkedIn and X.
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Investor Contact:
Per Hellsund, CEO, Cybrexa Therapeutics
860-717-2731
per.hellsund@cybrexa.com
Media Contact:
Robin Fastenau, Scient PR
robin@scientpr.com
CordenPharma International (Basel, Switzerland) and pHLIP, Inc. (Kingston, RI) are pleased to announce their strategic alliance to collaborate in developing and commercializing the pHLIP-LNP targeted delivery platform for RNA-based and genetic therapeutics. The alliance will combine CordenPharma’s proprietary Lipid NanoParticle (LNP) technology and GMP manufacturing expertise with pHLIP’s proprietary pH (Low) Insertion Peptide (pHLIP®) targeted delivery technology and drug development expertise to formulate (pHLIP®) coated LNPs for use by biopharmaceutical companies seeking to deliver mRNA-based and gene therapy payloads. Such payloads can be used to treat cancer, inflammation, and genetic diseases, or employ mRNA strategies for vaccination. The companies believe that their novel pHLIP-LNP platform will greatly enhance the commercial viability and success of many pioneering RNA, DNA and CRISPR therapies. The alliance will also enable CordenPharma and pHLIP to collaborate in developing and manufacturing small molecule drug payloads directly conjugated with (pHLIP®) peptides for biopharmaceutical companies seeking to selectively target their small molecular payloads into cells in acidic diseased tissues. CordenPharma serves as the CDMO supplier in the GMP manufacture of pHLIP® peptides and (pHLIP®) drug conjugates, and the new alliance further builds upon their collaborative efforts in this important field: https://cordenpharma.com/cordenpharma-and-phlip-announce-strategic-alliance-to-develop-phlip-lnp-targeted-delivery-platform/
The University of Rhode Island and Yale University granted pHLIP, Inc exclusive worldwide commercial rights for methods of use of pHLIP® compounds protected by a patent application developed by founders of the company and filed in October 2023.
After successful completion of phase I trial, the first patient has been dosed in a phase IIa fluorescence-guided surgical clinical trial evaluating pHLIP® ICG imaging agent in breast cancer surgery. The purpose of this study is to see whether the use of the fluorescent imaging agent pHLIP® ICG and NIRF imaging during surgery would allow the surgeon to image tumor bed and established tumor margins with high accuracy. The ClinicalTrials.gov identifier is NCT05130801, https://clinicaltrials.gov/ct2/show/NCT05130801
pHLIP, Inc. sublicensee, Cybrexa Therapeutics, has entered into an exclusive collaboration agreement with Exelixis, Inc. (Nasdaq: EXEL) providing Exelixis the right to acquire CBX-12. CBX-12 is composed of a pH-Low Insertion Peptide (pHLIP®), a linker and exatecan. Data from the ongoing phase 1 trial of CBX-12 in patients with metastatic solid tumors demonstrated preliminary anti-tumor activity in a heavily pretreated patient population. This included a complete response in a patient with ovarian cancer.
Under the terms of the agreement, Exelixis will pay Cybrexa an upfront fee of $60 million in exchange for the right to acquire CBX-12 pending certain Phase 1 results and to fund certain development and manufacturing expenses incurred by Cybrexa to advance an agreed development plan. Cybrexa may also be eligible to receive up to an additional $642.5 million, including development, regulatory, and commercial milestone payments, as well as a fee for the acquisition of CBX-12 upon evaluation of a pre-specified clinical data package.
Link to the announcement could be found here
The University of Rhode Island and Yale University granted pHLIP, Inc exclusive worldwide commercial rights for composition of matter and methods of use of pHLIP® immuno-modulator compounds protected by a patent application developed by founders of the company and filed in September 2022.
The first patient has been dosed in a phase I/IIa fluorescence-guided surgical clinical trial evaluating pHLIP® ICG imaging agent. The purpose of this study is to see whether the use of the fluorescent imaging agent pHLIP® ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to image tumor bed and established tumor margins. The ClinicalTrials.gov identifier is NCT05130801, https://clinicaltrials.gov/ct2/show/NCT05130801
The U.S. Food and Drug Administration (FDA) has provided green light to initiate first in human clinical studies of pHLIP® ICG imaging agent. pHLIP® ICG will be administered to breast cancer patients in a phase 1/2a fluorescence-guided surgical trial at Memorial Sloan Kettering Cancer Center. Fluorescence guidance by pHLIP® ICG during surgical procedures is expected to improve visualization of primary tumor masses and satellite cancerous lesions and allow accurate margin delineation to improve surgical outcomes.
Cybrexa Therapeutics announced that the first patient has been dosed in a Phase 1/2 clinical trial evaluating CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate. CBX-12 or alphalex™-exatecan is a pHLIP® Exatecan peptide conjugate: http://cybrexa.com/news/#
About Cybrexa: Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
Media Contact: media@cybrexa.com
Investor Relations
Westwicke, an ICR Company Stephanie Carrington
Stephanie.carrington@icrinc.com
646-277-1282
The Memorial Sloan Kettering Cancer Center and the University of Rhode Island granted pHLIP, Inc exclusive worldwide commercial rights for the composition of matter and methods of use of pHLIP® compounds protected by a patent application developed by founders of the company and filed in September 22, 2020.
Inventors of pHLIP® technology and founders from Yale University and the University of Rhode Island received a renewal of their NIH grant for the next 4 years (2020-2024) for the investigation and development of new pHLIP® Drug Conjugates (PDCs).